A summary of the GMP DIALOGUE at the GMP-BERATER Tage 2018
In the following, you can read a summary of the questions and answers that arose during the discussion at our GMP conference, the GMP-BERATER Tage 2018. GMP inspector Petra Rempe (PhD) and Peter Schulz (PhD) Head of e-technologies business unit at Provadis, responded to questions from interested GMP Publishing customers.
Training plans must be prospective and drawn up annually. All training dates should be fixed at the beginning of the year. It can be a detailed daily planning, but also a monthly or quarterly planning. It must be clear in each case which employees or functions receive which training. The planning can be employee-related, which can still be easily mapped for smaller companies, but can also be function-related. The training courses themselves can be classroom training, e-learning and reading training. GMP and/or GDP basic training and refresher training will always have to be planned. New topics are added, for example, by the introduction of new products.
The responsibility for training lies with the head of production, the head of quality control and the head of quality assurance. It must be ensured and comprehensible during the inspection that the training plans are checked and approved by those responsible (this is also valid for electronic planning systems).
The quality management systems of most companies are designed in such a way that the individual employee should actually know the contents of more than a hundred SOPs. In practice, things usually look quite different. The employee may know ten SOPs because only these directly affect him. From the legal and regulatory side, however, it should not pose a problem if it is determined that an employee is actually only trained in ten SOPs, for example, if this is sufficient for his area of deployment. The GMP regulations do not specify a specific scope, but require that employees must be trained for their area of work. The authority checks plausibility. In case of doubt, it may be advisable to coordinate the scope with the authority.
It is possible to gradate the SOPs in the form of a pyramid: There are higher-level SOPs that all employees should know. Then there are operational SOPs, which should know e.g. the head of production and the head of quality assurance, and beneath them the level of specific SOPs for production employees.
Presence training is preferable when it comes to topics that require practical training (e.g. hygiene training). The advantages of classroom training are also the interaction between the participants and the possible exchange of experience between long-standing and new employees. For the success of a classroom training, the instructor is the be-all and end-all - his qualification and his "pedagogical" talent.
Online training courses are particularly suitable for the training of theoretical content, as introductory training and, for example, for the training of SOPs - instead of reading training. Advantages are the independence of time and place as well as the possibility to adapt the training to your own learning pace. The computer-supported version is also suitable for refreshing learned practice contents. Here, for example, you can use interactive videos that suddenly stop and ask a question. Especially younger employees like to work with these systems. It is also possible for the employees themselves to make a film, e.g. on the subject of "How do I properly pass through personnel airlocks?“ The trainees can identify very well with what is shown ("That's Mrs. Müller from production!").
Playful elements can be very well used in classroom and online training. After the lunch break of a classroom training, a quiz with several teams can be carried out. Dry learning content thus remains better in the long-term memory.
With e-learning, it is important that it can be adapted to the specific needs and terminology of the company. The systems are constantly being further developed. There are now systems into which additional documents can be uploaded, as well as systems that can create e-learnings from PowerPoint presentations.
The external training provider (for both online and face-to-face training) is a service provider and should therefore be qualified accordingly. Keywords are here: reference list, life cycle and qualification of trainers. Is a coordinated, individual preparation possible? The feedback of the employees (feedback forms) should also be included in the evaluation of the provider.
A success check after routine training can be carried out relatively quickly and easily. The understanding of the trained material is queried. When a training course is held in order to avoid deviations or improve processes, parameters must be defined that make the success of the training course measurable. This can be done, for example, as part of the management review. Has the rate of deviations or complaints improved? If there is no improvement, the solution cannot be to repeat the training several times. Rather, the underlying cause must be identified. Is it the employees? Is the associated SOP faulty or insufficient?
In general, a company must determine in a procedure when additional training should take place. To this end, suitable indicators must be defined and continuously collected and checked for trends. For example, it may be acceptable that 0.5% of the fingerprints of employees in the cleanroom are positive (as long as it is not always the same employee). A plausible and documented justification for the procedure is important.
Control of the effectiveness is also carried out by monitoring and evaluating compliance with certain parameters. The challenge is to establish meaningful parameters that can actually be used to draw conclusions about the effectiveness of the training.
The EU GMP Guidelines specify in paragraph 1.5 of Chapter 1:
Senior management has the ultimate responsibility to ensure an effective Pharmaceutical Quality System is in place, adequately resourced and that roles, responsibilities, and authorities are defined, communicated and implemented throughout the organisation. Senior management’s leadership and active participation in the Pharmaceutical Quality System is essential. This leadership should ensure the support and commitment of staff at all levels and sites within the organisation to the Pharmaceutical Quality System.
Accordingly, senior management is responsible for the implementation of the training courses and the creation of the corresponding resources. The authority would have recourse to the managing director in case of deficiencies. However, those responsible for training in their companies often find themselves in the area of conflict between the management, which does not see the need for training and does not support it, the employees to be trained and the requirements of the authority. Within the framework of a trustful cooperation with the supervisory authority, it is possible that a reference is given to the inspectors where there is still a lack of understanding and support of the management. In this way, the authority can provide support to those responsible for GMP compliance by addressing specific points in a targeted manner.
In Germany the works council is subject to codetermination when it comes to training. As a rule, however, a jointly agreed path is always found. Learning and success controls are required by law and are generally accepted by works councils. An anonymous evaluation is important for the works council. Especially in e-learning, the danger is often seen that the supervisor could have insight into the data of the employees.
The company, together with the works council, must establish a procedure in the event that employees do not pass the training. Here it is advisable to identify the employees concerned by name in order to be able to follow them up in a targeted manner.